Beruflich Dokumente
Kultur Dokumente
ISO 9001:2015
INTERPRETATION &
DOCUMENTATION
COURSE
8-9 Oktober 15
Dewi Almitrasari
Lead Auditor & Trainer
Benefits to you!
Welcome!
Delegate Introductions
Introductions
Course Aim
To gain an understanding of effective
quality management, by using a
systematic framework to:
A) Consistently provide products or
service that meet requirements
B) Enhance customer satisfaction
C) Develop effectiveness of
documentation system
Learning Objectives
The
The history
history and
and
development
development of
of
ISO/FDIS
ISO/FDIS 9001
9001
What
What is
is a
a Quality
Quality
Management
Management System
System
(QMS)
(QMS)
The
The benefits
benefits of
of a
a QMS
QMS
Have
Have the
the skills
skills to
to develop
develop
documentation
:
documentation :
process
process mapping
mapping
documented
documented information
information
such
such as
as procedure
procedure and
and
supporting
supporting document
document
KNOWLEDGE
The
The terms
terms and
and
definitions
definitions used
used
Key
concepts,
Key concepts,
principles
principles and
and
structure
structure
The
The main
main requirements
requirements
of
of ISO/FDIS
ISO/FDIS 9001:2015
9001:2015
and
and how
how to
to implement
implement
SKILLS
QMS
QMS shall
shall establishing
establishing the
the
documented
documented information
information for
for
the
the effectiveness
effectiveness (Clause
(Clause 7.5,
7.5,
ISO
FDIS
9001:2015)
ISO FDIS 9001:2015)
Overview
Knowledge
Identificatio
n
Understanding the
requirements of
the
standard is your
essential starting
point to working
with
a management
system.
Develop your
expertise to
identify the
document and
other to
comply the
requirement
4
Documentati
on
Discover how
you
can develop the
documentation
system
1/20/17
Copyright 2015 BSI. All rights
reserved.
tion
Training
Agenda 2 days Course
duc
Intro
Module 2
Overview
Module 1
Principle of QMS
Terminology
(Workshop 1)
Concept of Quality
Module 9
Interpretation &
Documentation of
Performance Evaluation
Customer Satisfaction
Internal Audit
Management Review
Module 10
Interpretation &
Documentation of
Improvement
Improvement
Nonconformity & Corrective action
Continual Improvement)
Closing
Module 3
ISO 9001 - General
Historical of ISO 9001
ISO 9000, ISO 9001 &
ISO 9004
Module 8
Interpretation &
Documentation of
Operation
Planning and provision of services
((Workshop 5)
Control of external providers
Release & Control of Non Conforming
Module 7
Interpretation &
Documentation of
Resources
People
Infrastructure
Process Environment
Monitoring & Measurement
Knowledge Management)
Competence
Awareness
Copyright
2015 BSI. All rights
Documented Information(Workshop 4
reserved.
Module 4
Interpretation &
Documentation of
Context Organisation
Interested Party
Scope
Process Mapping (Workshop 2)
Module 5
Interpretation &
Documentation of
Leadership
Commitment
Quality Policy
Role & Responsibility
Module 6
Interpretation &
Documentation of
Planning
Risk Management
(Workshop 3)
Quality Objective
Management of Change
8
Time Table
08 October 2015
08.00 Opening & Introduction
08.20 Module 1 : Concept of Quality
09.00 Module 2 : QMS Overview & Workshop 1
09.40 Module 3 : QMS Historical
10.00 Break
10.15 Module 4 : Context Organisation & Workshop 2
12.00 Ishoma
13.00
Module 5 : Leadership
Break
15.15
16.30
Time Table
09 October 2015
08.00 Review of day 1 materi
08.15 Module 7 : Resources and workshop 4
10.00 Break
10.15 Continued with module 7
11.00 Module 8 : Operation
12.00 Ishoma
13.00
15.00
Break
15.15
End of course
10
Course Structure
Materials:
Delegate workbook
Loan copy of ISO 9001
Course Format:
Activities
Classroom discussions
11
12
Who is BSI?
Leading Global Standards Creation Body: British, European, ISO, Public, Private
Global Network: 72,000 clients in 150 countries worldwide including governments, global brands and
SMEs
Experienced: The worlds first National Standards Body established in 1901 and a founding member of
ISO
Thought Leaders: Shaped the worlds most adopted standards, incl. ISO 9001, ISO 14001, OHSAS
18001
Trusted: Were a Royal Charter Company, reinvesting profits back into our business to improve our
clients experience
1/20/17
13
Support
Assess
Embed
Share
Shape
Together with >10,000
independent experts,
BSI leads in the
development and
maintenance of global
standards
Public
Public Standards
Standards -- PAS
PAS
British Standards - BS
European
European Standards
Standards -EN
EN
ISO
ISO Standards
Standards
We share our
standards and
guidance documents
in many formats,
from paper to PDF or
organization-wide
licenses
Online Standards
Portal
Portal
Network
Network Licenses
Licenses
R i s k
S u s t
O p e r
M a n a
a i n a b
a t i o n
In-Company
In-Company Training
Training
Public Training
Training
Public
Internal
Internal &
& Lead
Lead
Auditor
Auditor Training
Training
Self
Self Assessment
Assessment
tools
Gap
Gap Analysis
Analysis
g e m e
i l i t y
a l P e
Entropy
Entropy Software
Software
BSI Excellerator
Report
Report
Supply
Supply Chain
Chain
Solutions
Solutions
Six
Six Sigma
Sigma Training
Training
Business
Business Improver
Improver
Training
Training
n t S t a n d a r d s
S t a n d a r d s
r f o r m a n c e S t a n d a r d s
14
Standardisasi
Sertifikasi
International Accreditation Forum
Certified once, accepted everywhere
UK
Accreditation Body
USA
Accredit
s
Certification Body
Organization
15
Year
British
Standard
ISO Standard
1987
BS 5750
1992
BS 7750
1995
BS 7799
1996
BS 8800
2000
BS 8600
2002
BS 15000
2002
TS 16949
2009
BS 16001
2009
BS 5750 (based)
AS 9100 (Aerospace)
2012
BS 25999
2012
BS 8901
16
1
Concept of Quality
MUTU
18
Copyright 2015 BSI. All rights
reserved.
18
Quality ? Mutu ?
Quality
Management /
Manajemen Mutu
Quality
Control/
Kendali
Mutu
Quality
Assurance /
Jaminan Mutu
19
Philip Bayard
Crosby (19262001):
Joseph Moses
Juran (1904
2008)
William Edwards
Deming (19001993)
20
Q Performance
Q Performance
SUSTANAIBILITY
SUSTANAIBILITY
(ISO 9001:2008)
(ISO 9001:2008)
QUALITY
MANAGEMENT
Quality
Quality
Assurance
Assurance
PERFORMANC E
Quality Control
Quality Control
ZERO DEFECT
ZERO DEFECT
Quality Inspection
Quality Inspection
COMPLIANC
E
21
22
Management ?
Coordinated activities to direct and
control an organization
Quality Management ?
Management with regard to quality
Quality Management System
?
Management system with regard to
quality
Quality
management
systems
Fundamental
s
and
vocabulary
23
Workshop 1a
15 minutes
Click here to
start
24
Sistem manajemen
Integrasi dari keseluruhan sistem
25
KEBIJAKAN
SASARAN/TARGET
STRATEGI
Plan
Do
PROGRAM
SISTEM DOKUMENTASI Metode pencapaian sasaran : prosedur,
Action Check
PENERAPAN
PEMANTAUAN,
EVALUASI & TINDAK
LANJUT
Copyright 2015 BSI. All rights
reserved.
26
Mengapa kita
perlu sistem ?
27
Integrasi = Keterkaitan
SASARAN MUTU
PROSES
DOKUMENTASI
TUJUAN
28
HARAPAN
CUSTOME
R
KEBIJAKAN &
SASARAN, PROGRAM
Personel
Peralatan
Tg. Jawab&wewenang
Kompetensi/Kualifikasi
Pelatihan
Record
Ketersediaan
PROSES
PLAN
DO
Informasi/Metode
Material
Kebutuhan
Ketersediaan
Kemampuan
Pemeliharaan
Kondisi
Spesifikasi
Ketersediaan
Penyimpanan
Pengadaan
Kondisi lingkungan
Penetapan
Pengelolaan
Kebutuhan
Spesifikasi
Akurat
Analisa
Komunikasi
Ketersediaan
ACTION CHECK
29
Sasaran mutu
organisasi
Hasil
pencapaian
Peningkatan
% 100
0
75
50
25
30
2
Management Principle
Customer
Focus
Leadership
Engagemen
t of People
Process
Approach
Improveme
nt
Evidencebased
Decision
Making
Relationshi
p
Manageme
nt
32
Organisasi tergantung
pada pelanggan
Persyaratan Pelanggan
Prinsip 1:
Customer Focus /
Fokus Pelanggan
Kepuasasn Pelanggan !
Copyright 2015 BSI. All rights
reserved.
33
Prinsip 2:
Leadership /
Kepemimpina
n
Copyright 2015 BSI. All rights
reserved.
34
Prinsip Ke-3
Engagement of
people
35
Prinsip Ke-4
Pendekatan
proses
Copyright 2015 BSI. All rights
reserved.
36
Understandi
ng
requirement
s
(Outputs)
(Inputs)
Process
Intended
results
Processes adding value
Processes providing effective performance
Improvements (through evaluation) of
data/information
PDCA (process) methodology (Fig. 2)
Copyright 2015 BSI. All rights
reserved.
Activities
understood
and managed as
interrelated
processes
Consistent,
predictable results
Meeting
requirements
Customer
satisfaction
37
Peningkatan
berkelanjutan
haruslah menjadi sasaran tetap dari
organisasi
Prinsip Ke-5
Peningkatan
38
Sasaran mutu
organisasi
Hasil
pencapaian
Peningkatan
% 100
0
75
50
25
39
Prinsip Ke 6
Pendekatan Fakta/bukti untuk
keputusan
40
Organisasi
dan
pemasoknya
selalu
tergantung satu sama lain dan hubungan
yang saling menguntungkan meningkatkan
kemampuan dari kedua belah pihak untuk
menghasilkan nilai tambah yang lebih
besar.
Prinsip Ke-7
Relationship Management
41
Workshop 1b
Quality Management
Principle
15 minutes
Click here to
start
42
3
ISO 9000 Family
D
D&
&
D
D
BSI
Pellentesque mollis
felis dolor, quis
aliquet sapien
dapibus tempus
lectus. Nulla sed
posuere velit, ut
gravida nibh.
BSI
Quality systems
British Standard
Quality systems
British Standard
Quality systems
British Standard
44
BS EN ISO 9000
BSI British
Standards
BS EN ISO 9004
BSI British
Standards
Quality
managemen
t
systems
Fundamental
s
and
vocabulary
Managing for
the
sustained
success of an
organization
A quality
management
approach
45
BS 5750
Part 2:1979
1st edition :
ISO 9001:1987
ISO 9002:1987
ISO 9003:1987
2nd edition :
ISO 9001:1994
ISO 9002:1994
ISO 9003:1994
3rd edition :
ISO 9001:2000
BS EN ISO 9001
BSI Standards Publication
Quality Management
systems Requirements
e
l
e
se
.
p
e
4th edition :
5th edition :
ISO 9001:2008 ISO 9001:2015
BS EN ISO 9000
BSI British
Standards
Quality management
systems
Fundamentals
and vocabulary
BS EN ISO 9004
BSI British
Standards
Managing for the
sustained success of
an
organization A
quality
management
approach
46
Accredited Certification
Accreditation Body
Accredit
s
Certification Body
UKAS, or
equivalent local
national body
BSI, or esteemed
competitor
Personnel
Certification Body
Certificate
s
Auditor
User
Organization
Train
s
eg IRCA
Accredit
s
Training Course,
Tutor,
Training Body
Audits
47
Nama Perusahaan
dan alamat
Ruang Lingkup
aktifitas
Tanggal penerbitan
dan masa berlakuk
sertifikat
Badan sertifikasi
dan lembaga yang
mengakreditasi
Copyright 2015 BSI. All rights
reserved.
48
Stage 1
Audit
PreAudit
Corrective
Action
OPTIONAL
major
Corrective
Actions
6-monthly
Surveillance
Audit
Stage 2
Audit
major
major N
Follow-up
audit
Y
Corrective
Actions
3 year
Max.
3
months
Corrective
Actions
Max.
3
months
Follow-up
audit
49
Scope
Planning
Normative references
Support
Operation
Context of the
organization
Performance evaluation
5
5
Leadership
10
1/20/17
10
Improvement
50
1) Scope
2) Normative
references
3) Terms and
definitions
51
52
4
Context of Organisation
Clause 4 - ISO 9001:2015
Understanding the
organization and its context
54
Determine:
Purpose
and
strategic
direction
Applicabili
ty
Products
and
services
Intended
result(s)
of QMS
External
and
internal
issues
Organization
Boundarie
s and
applicabili
ty (Scope)
Requireme
nts of
these
interested
parties
Copyright 2015 BSI. All rights
reserved.
Interested
parties
relevant
to the
QMS
55
Top Management
Those accountable
for Quality policy
and implementation
Commentators
Trade groups
Neighbors
Pressure groups
Other response
agencies
Other Staff
Staff dependents
Contractors
Emergency services
Transport services
56
57
Organisasi harus:
mengidentifikasi proses-proses yang diperlukan
Peta
Proses
58
59
With what?
(resources)
Inputs?
(what,
from
whom)
PROCESS
Outputs?
(what,
to whom)
What results?
(monitoring, measurements,
performance indicators)
How done?
(criteria, methods/controls
documentation)
60
Understandi
ng
requirement
s
(Outputs)
(Inputs)
Process
Intended
results
Processes adding value
Processes providing effective performance
Improvements (through evaluation) of
data/information
PDCA (process) methodology (Fig. 2)
Copyright 2015 BSI. All rights
reserved.
Activities
understood
and managed as
interrelated
processes
Consistent,
predictable results
Meeting
requirements
Customer
satisfaction
61
Support and
Operation
( 7,8)
Do
Plan
Customer
requirement
s
Planning (6)
Leadership
(5)
Act
Needs and
expectations
of relevant
interested
parties (4)
Performanc
e evaluation
(9)
Check
Improveme
nt (10)
Customer
satisfaction
Results of
the QMS
Products
and
services
62
Pendidikan &
Pengajaran
Workshop
Fungsi
Perbaikan dan
Perawatan
Laboratorium
Fungsi
MIS
Perpustakaan
Penelitian dan
Pengabdian Pada
Masyarakat
Fungsi
Publikasi
Fungsi
Penjaminan
Mutu
Bg Umum,
Administrasi
dan keuangan
Lulusan,Industri,
Masyarakat
Business process mapping sebagai peta aliran fungsi untuk menjelaskan interaksi antar
fungsi dan menjadi fondasi dalam menetapkan key performance indikator yang efektif
dengan berlandaskan kaidah next process is our customer dan kaidah quality built by
every proceses within organization
63
Laboratorium
Workshop
Review dan
Improvement
Process
PEN-01
PEN-03
Prosedur Proses
Prosedur Pelaksanaan
dan Evaluasi Ujian
Semester
Belajar Mengajar
UPT Perbaikan
dan Perawatan
Unit MIS
Bagian Akademik
dan Administrasi
Kemahasiwaan
PEN-04
Prosedur Bimbingan dan
Administrasi Tugas Akhir
Unit
Publikasi
P3M
Bg Umum,
Administrasi
dan keuangan
64
Business Process
SP-01
Planning
CP-01
PP-01
WI-XX-01
(Penerimaan
Mhs baru )
Order Processing
Litbang
SP-02
CP-02
RID-01
Umum
WI-XX-02
(Pembuatan
Kartu Tanda
Peserta Test)
Logistics
SP-03
QA, MR
65
66
< Procedure>
Human resource
management process
Sales marketing process
Production
management process
Equipment control
procedure procedure
Purchasing
Production procedure
Inspection procedure
67
Contoh
MATRIKS KORESPONDENSI "DOKUMENTASI - STANDARD"
No
Departemen/
Proses
Nama
Dok.
No
Dok.
68
5
Leadership
Clause 5 - ISO 9001:2015
Leadership and
commitment for the
quality management
system
Customer focus
5. Leadership
5.3. Organizational
roles,
responsibilities and
authorities
70
71
FOKUS KE PELANGGAN
Persyaratan pelanggan dan peraturan
yang berlaku telah ditetapkan, dipahami
dan dipenuhi secara konsisten
Top manajemen
harus menjamin:
72
73
74
6
Planning
Clause 6 - ISO 9001:2015
Issues
6.1
Determine risks and opportunities
9.2
6.1
Plan actions to address risks and opportunities
76
Equity Risk
Market Risk
Credit Risk
Specific
Risk
Trading Risk
Gap Risk
General
Market
Risk
Commodity Risk
Operational
Risk
Risks
Reputational
Risk
Business and
strategic risks
Counterparty
Risk
Transaction Risk
Issuer Risk
Portfolio
Concentration
Risk
Issue Risk
77
Threat map
78
Identify
Risk
Understand
and analyse
the business
Focus on
strategic
issues
Assessment
of Controls
Business
Management
Assess
business
risk
Assess
implemented
risk control
Strategy
Planning
Implementation
Monitoring
Improvement
Prioritising
of critical
risk
Improved
internal
control
Assessment
of Risk
Managed
Business
79
Risk
Identification
Risk Analysis
Risk
Evaluation
Impact significant
but likelihood
unknown (high
uncertainty)
Unable to
qualify as
likelihood
unknown
Risk Treatment
Residual risk
Subscribe to Economic
indicators service for
horizon scanning
economic conditions and
global trends
Unknown
pending horizon
scan. Re-evaluate
on report receipt.
Tolerate risk.
Transfer
emergency funds
to holding
company
Neighbourh
ood
disruption in
street
cabling
New fibre
technology
available
Workforce
retention
Share
holders:
Stock
market
crash
Economic
Significant
effect on profit
objectives and
liquidity if
share price
collapses
80
Procurement Risks
HSE Risks
FEED Docs in ITB Docs are not RFQ & RFP documents are HSE Project Plan
detail and incomplete additional not clear such as : Scope of Implementation. High
some procentage for Bill of
Supply, Data Sheet, Bill of
standard will impact to
Quantity calculation may
Quantity, Specification, Test project cost and schedule
required.
Witness, Chemical
/Oil/Grease Supply, Spare
Part For Commissioning & 2
Years Operations, engineering
document should be supply,
Fabrication Schedule,
Packaging Specification,
General Condition, etc are not
clear.
Plot Plan, P&ID, One Line
Diagram & Hazardous Area
Change
Inaccurate assumptions on
technical issues in planning
stage
Surveys incomplete
Organizational
Risks
Unanticipated
project manager
workload
Internal red tape
causes delay
getting approvals,
decisions
Functional units
not available,
overloaded
Overlapping of one
or more projects
Terms &
Conditions
Contract Risks
New
alternatives
required
support
Copyright
2015
BSI. All Underestimated
rights
toreserved.
avoid, mitigate or
resources or overly optimistic
Lack of specialized
staff or Skilled MP
resources are
limited.
81
82
83
84
A Closer Look
Prioritize
85
Workshop 3
Risk Management
45 minutes
Click here to
start
86
87
Risk
Analysis
progressing
Risk A
Objectives A
Risk B
Objectives B
Risk C
Objectives C
Future
Future
Situation
Situation
Vision
Mission
Institusional
objectives
Performance
indicators
Copyright 2015 BSI. All rights
reserved.
88
89
7
Resources
Clause 7 - ISO 9001:2015
Clause 7: Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
91
7.1.2 Sumber
Daya Manusia
organisasi harus
menyediakan orang-orang
yang diperlukan untuk
efektifitas operasi dari
sistem manajemen mutu,
termasuk proses yang
diperlukan.
7.1.3
Infrastruktur
7.1.4 Lingkungan
Kerja
Organisasi harus
menetapkan,
menyediakan dan
memelihara lingkungan
yang diperlukan untuk
operasi dari proses untuk
mencapai kesesuaian
produk dan jasa.
Lingkungan dapat mencakup
fisik, sosial, psikologis,
lingkungan dan faktor
lainnya (seperti suhu,
kelembaban, ergonomi dan
kebersihan
92
93
94
Other support
Kompetensi (7.2)
Organisasi harus:
menentukan kompetensi yang
diperlukan untuk orang (s) yg.
melakukan pekerjaan di bawah
kendalinya dapat mempengaruhi
kinerja mutu;
memastikan bahwa orang-orang ini
kompeten atas dasar pendidikan,
pelatihan, atau pengalaman;
di mana berlaku, mengambil tindakan
untuk memperoleh kompetensi yang
diperlukan, dan mengevaluasi
efektivitas tindakan yang diambil;
menyimpan informasi terdokumentasi
sebagai bukti kompetensi.
CATATAN tindakan Berlaku dapat meliputi,
misalnya, penyediaan pelatihan, mentoring,
atau re-assigment orang saat ini bekerja;
atau mempekerjakan / mengontrak orang
yang kompeten.
Kepedulian (7.3)
Komunikasi (7.4)
Orang yang
melakukan
pekerjaan di bawah
kendali organisasi
harus peduli
terhadap:
kebijakan mutu;
sasaran mutu yang
relevan;
kontribusi mereka
terhadap efektivitas
SMM, termasuk
manfaat dari
peningkatan kinerja
mutu;
implikasi
ketidaksesuaian
persyaratan sistem
manajemen mutu
95
96
Pengendalian dokumen
menyetujui dokumen akan kecukupannya sebelum diterbitkan,
meninjau dan memperbaharui seperlunya dan menyetujui ulang
dokumen,
memastikan perubahan dan status revisi terkini,
versi relevan dari dokumen yang berlaku tersedia di tempat
pemakaian,
dapat dibaca dan mudah dikenali,
Pengendalian dokumen yang berasal dari
luar
mencegah pemakaian tak disengaja dari dokumen obsolete
(kadaluarsa)
97
98
1/20/17
Copyright 2015 BSI. All rights
reserved.
98
Workshop 4
Documentation
30 minutes
Click here to
start
99
8
Operational
Clause 8 - ISO 9001:2015
Clause 8: Operation
Operational planning
and control
Requirements for products and
services
Design and development of products
and services
Control of externally provided products and
services
Production and service
provision, including
release
Control of nonconforming
process
Copyright 2015 BSI. All rights
reserved.
10
1
8.1. Operational
planning and control
8.1 Perencanaan dan Pengendalian Operasional
Merencanakan, menerapkan
dan mengendalikan proses
yang diperlukan untuk
realisasi produk.
Perencanaan realisasi
produk harus taat azas
dengan persyaratan
Menetapkan :
Kriteria proses
Pengendalian perubahan
Pengendalian outsource
10
2
10
3
10
4
10
5
8.3.4. PENGENDALIAN
DISAIN &
PENGEMBANGAN
Evaluasi kemampuan
pemenuhan persyaratan
VERIFIKASI (Self-checking,
Pemeriksaan oleh
personel/Team yang
independent , Metode
pembanding (Kalkulasi atau
evaluasi design yang serupa),
Test, simulasi atau uji coba
8.3.2. PERENCANAAN
DISAIN &
PENGEMBANGAN
VALIDASI, Memastikan
sesuai dengan keinginan
Tahapan proses
10
6
10
7
10
8
10
9
11
0
Workshop 5
Process Identification
30 minutes
Click here to
start
11
1
Organisasi harus:
identifikasi produk dengan cara sesuai diseluruh
realisasi produk , jika diperlukan
identifikasi status produk berkaitan dengan persyaratan
pengukuran dan pemantauan
mengendalikan dan merekam identifikasi khas dari
produk, bila mampu telusur dipersyaratkan
11
2
harus:
diidentifikasi
diverifikasi
dilindungi dan dijaga
milik pelanggan atau provider eksternal yang hilang, rusak atau
karena suatu hal tak layak pakai harus direkam dan dilaporkan
Property mencakup intelektual property
11
3
8.5.4. Preservasi
11
4
11
5
11
6
11
7
11
8
9
Performance Evaluation
Clause 9 - ISO 9001:2015
12
0
9.1.2
(Customer
satisfaction)
9.1.1
(General)
12
1
9.1.2. Customer
Satisfaction
UNANTICIPATED
DESIRED
EXPECTED
BASIC
Standar minimun
yg diterima
Nilai rata-rata
(sama seperti
jasa lainnya)
Apa yang
diinginkan
pelanggan
Melebihi apa
yang
diinginkan
pelanggan
Faktor Kepuasan
Faktor loyalitas pelanggan
Copyright 2015 BSI. All rights
reserved.
12
2
At
Atplanned
planned
intervals
intervals
(status
(statusand
and
importance)
importance)
Ensure
Ensure
system
system
conforms
conformsto
to
planned
planned
arrangement
arrangement
ss
Ensure
Ensure
system
system
conforms
conformsto
to
ISO
9001
ISO 9001
Effectively
Effectively
implement
implement
ed
edand
and
maintained
maintained
Follow-up
Follow-up
actions
actions
Audit
Auditcriteria,
criteria,scope,
scope,frequency,
frequency,methods
methodsdefined
definedin
indocumented
documented
information
information
12
3
12
4
Management Review
WHAT NEEDS
TO CHANGE?
CONSIDER:
Previous actions/
status
External/
internal issues
Opportunities (C.I)
N/Cs,
corrective actions
Monitoring/
Measurement
REVIEW
REVIEW
Changes to QMS
Audit results
Customer satisfaction
External providers
Adequacy of
resources
Resource needs
Process performance
Risks and
opportunities
Continual
improvement (C.I)
Doc. Information
12
5
1
0
Improvement
Clause 10- ISO 9001:2015
12
7
Improvement
12
8
What to
evaluate ?
Policy
Critical Success
Factor
How to
evaluate ?
Data collected
Analyze
Responsibility
Measurement
Frequency
Program
Method
Action
Corrective
Correction
Improvement
Copyright 2015 BSI. All rights
reserved.
12
9
13
0
Continual improvement
QUALITY PROBLEM
CORRECTIVE ACTION
Operational Cost
Caused identification
Non conformity
Performance
Follow up
Implementation monitoring,
efficiency and evaluation on its
effectiveness
PREVENTIVE ACTIONS
POTENTIAL
Caused identification
PROBLEMS
CONTINUAL
IMPROVEMENT
13
1
Continual improvement
13
2
13
3